Medsider: Learn from Medtech and Healthtech Founders and CEOs - Mission-Driven Entrepreneurship: Interview with NEXT Life Sciences’ Founder L.R. Fox

Episode Date: September 13, 2023

In this episode of Medsider Radio, we pull back the curtain on L.R. Fox, the visionary founder of NEXT Life Sciences. With an ambitious mission to democratize family planning, Fox and his team are on the brink of launching their flagship product, Plan A— a groundbreaking male contraceptive.Before founding NEXT Life Sciences, Fox was already a powerhouse entrepreneur in numerous highly regulated industries ranging from cybersecurity to aerospace, including WhiteFox Defense Technologies, a company that is shaping the future of drone airspace security. With a degree in engineering and as a member of the Forbes' 30 Under 30 list in 2019., Fox is currently leading NEXT’s efforts to introduce Plan A to the market. In this interview, Fox shares invaluable lessons on fostering collaboration in a competitive space, understanding key stakeholders, and the art of raising capital. Whether you're an aspiring entrepreneur or simply curious about how innovation can drive societal change, this conversation offers key takeaways for all.Before we dive into the discussion, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd much rather read, here's a link to the full interview with L.R. Fox.

The rising tide really does raise all ships. It's really easy for people to get hyper-competitive, and maybe there's a time and space for that. But when you're creating a new industry, I think it's something I've found is instead of looking at people's competition, to really say, like, how do we partner together to create something here?

Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott.

In this episode of Medsider, I sat down with Luke Fox, founder of Next Life Sciences and a powerhouse entrepreneur with experience in numerous highly regulated industries ranging from cybersecurity to aerospace, including White Fox defense technologies. With a degree in engineering and a member of the Forbes 30 under 30 list in 2019, Luke is currently leading next life sciences efforts to introduce a pioneering male contraceptive to the market. Here for you the key things that we discussed in this conversation. First, in emerging markets, there is often room for multiple players to thrive. Fostering collaboration often yields greater results than intense competition.

That's why taking a human-centric approach to resource management can often be more effective than merely relying on financial incentives alone. Second, the adoption of a product hinges on the complete understanding of your target market, which includes stakeholders beyond your immediate, users like care partners, payers, and even skeptics. Engaging with these groups will allow you to capture pertinent insights across the life cycle of your technology from development to commercialization. Third, fundraising is more about finding investors aligned with your mission than it is about

securing money. Here, authenticity is key and rejection can be a stepping stone to better opportunities. Working on a technology with broader social impact can also further enhance investor appeal. Before we jump into this episode, I wanted to let you know that we just released the latest edition of Medsider Mentors Volume 3, which summarizes the key learnings from the most popular medsider interviews over the last several months with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajun vascular, and other leaders of some of the hottest startups of the

space. Look, it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes

conversations with experts like Nadim Yared, CEO of CVRX, Renee Ryan, CEO of of Cala Health and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. All right, Fox, welcome to Medsider Radio. Appreciate you coming on, man. Thanks for having me, Scott. Yeah, definitely looking forward to the conversation,

especially considering all of that you've done in a, I mean, you're a young guy, you know, so in a relatively kind of short career, you've done a lot. So excited to have this conversation and especially to learn a little bit more about what you're building at next in Plan A. But I recorded a brief bio at the outside of this interview,

So let's start there. I'd like to hear your own kind of your own words. If you can give us kind of an elevator pitch for what you've been doing, kind of leading up to founding next and plan A. That'd be helpful. Yeah, absolutely. So, you know, my background has been in really creating new categories across highly regulated industries. I love when there's a big problem that exists that we can say,

let's take a step back and see how do we address this thoughtfully. My last companies were in cybersecurity and defense and aerospace. all of these spaces that where there's a need to have high certainty around what you're building and to think not just a couple years in the future, but think about generational impact. And that's really very much the same within the healthcare and med tech space, is how do we create things that really have a diverse set of applications and do so in ways that create new categories. Got it, got it.

Yeah, I almost like that. I was looking at your bio kind of leading up to this interview and kind of doing a little bit of research. And I get the sense that you're kind of like a Palmer Lucky a little bit, right? You know, I don't know if you'll eventually get into the life sciences, but you go from like pretty cool kind of defense, you know, company and now kind of doing something really cool with Next and Plan A. So again, for everyone listening, you know, we'll link to Fox's LinkedIn profile in the full summary on MedSider for this interview. You can definitely check that out in more detail. But let's talk a little bit, at least at a high level, and we'll get into probably more details for sure.

But talk to us a little bit more about Next and Plan A and kind of really kind of the origin story for how the technology kind of, or the idea for the technology came to me. Yeah. So the origin of it was I was actually doing some work with the U.S. Chamber of Commerce and was sitting at the White House. And we were talking about how do we use innovation to make people's lives more prosperous? and so everything from flying cars and AI and drones and all these amazing technologies. And it really just like hit me like a brick in the face. I was like, wait a second. Like there's all these amazing technologies that need to happen and that will happen.

But we're missing this fundamental, what I believe is a human right that we've in many ways ignored, which is that ability to choose when and if to have a child. And to me, that is something that when you look at that, not just to me, I should say also with just the stats. It's known as the social dial. It's like the one thing that you can dial and by increasing people's ability to choose when and if to have a child, that family planning,

you can help them from everything from education to social economic to other health indicators. And so it just really hit me. Again, like a break of the face. We are still living in this modern day where half-all pregnancies are unplanned. And that's not in some far off part of the world, but that's here in the United States.

And so that really was the genesis of Next, which is how do we really look at this in a whole new way that hasn't been addressed previously? How do we create a new category here where instead of just making these small incremental changes, how do we make a quantum leap in providing people this ability to make the most important choice of their life? I don't think I realized that.

50-ish percent of all pregnancies are on plan. No kidding. I did not realize that. Flip odds. Yeah, yeah, yeah. No, no doubt. Not ideal, not ideal for sure. So you mentioned Next, and I've mentioned Plan A a couple times now.

So how do we understand it, is Plan A, like, is Plan A the first of many companies under the next umbrella? Or talk to us a little bit more maybe about kind of what you, what you're planning for. And then, like, let's drill into Plan A specifically. Absolutely. So when we look at this, Next Life Sciences is focusing on creating solutions, allow people to be able to make that choice. when and if to have a child. Our flagship product is known as Plan A. It's a Plan A contraceptive system.

This is designed to be the world's first male birth control that's long-lasting and reversible. And that's important because when you look at what men and women and anybody seeks in birth control and a contraceptive is, again, that is known as a lark. I'll put it that way. It's known as a lark, L-A-R-C, right? It's long-acting. Like you set it and you forget it. and then it's reversible. Controception, L-A-R-C, right?

And so you set it, you forget it, you turn it on, and then you turn it off when you're ready to have a child. That is the holy grail of contraception, and Plan A is really set up to be the first Lark for men. Got it, got it. My wife, we've got five kids, right? So we've never really, you know, struggle necessarily in this area.

But I totally get the idea of like unplanned, right? Because we've, in fact, our fifth, there's a decade apart from our four. and or fifth. So yeah, he wasn't necessarily planned per se. But on that note, I've always thought, like, you know, the whole like contraceptive kind of aspect, at least for like semi permanent contraceptive or permanent, semi permanent to permanent country. Always the responsibilities are like almost always put on the female, right? And then for guys, I guess there's always a vasectomy. It's so permanent. And like you always hear these horror stories about like, you know,

guys wanting to reverse vasectomy. So it seems like kind of one of those things that we almost take for granted. It's like no one's ever, it's weird. It's like no one's ever like innovated. It seems like it. No one's really ever innovating in this in this category. So, and again, we'll dig into this in a little bit more detail here. But, you know, talk to us a little bit more about kind of the magic sauce for plan A, so to speak, because it does seem like you're working on a bit of a Holy Grail, as you mentioned. But what is this?

Like, how does this actually work? Because it seems pretty cool, right? If it actually pans out the way or, you know, the way it looks. Yeah. So the technology is designed to be a quick, simple, 10-minute pain-free procedure, right? go to the doctor, and in doing so, it's a simple injection of our proprietary hydrogel into the vast deference. Now, the vast deference is a little tube that carries sperm.

In a mesectomy, that's what gets snipped and coterized. And we say, you know, why go through the process of sniffing, cauterizing, you know, and destroying the tissue when you can simply inject this hydrogel. And this hydrogel goes in as a liquid and then very quickly forms as a matrix. And so the liquid goes out and you're left with this micro filter. And this microfilters is designed to be exactly the right size to allow all fluid to pass through except the sperm. Now, this is going through testing currently and we've had a lot of really positive results. But the design is really to create this flexible filter, very simple to implant and then very simple to reverse with a quick injection of sodium bicarbonate.

that is designed to it to turn it from that flexible filter, that solid, back into its liquid form and it gets fleshed out. And that's the second procedure, right? I would have answered. So like, I get plan A and then fast forward a couple years, I'm like, okay, we're ready to go. That's the second procedure. It's just some sort of like, is that proprietary too?

Something that almost dissolves that matrix that you mentioned? Well, it's actually really important that it's not proprietary. So because what we want to ensure is that anybody, no matter where they are in the world, no matter what happens, they are able to do it themselves. So simple sodium bicarbonate baking soda. Now, we don't recommend that, right? So you go to the doctor, you get the quick simple injection, but it really allows a democratization of contraception. Got it.

Okay, that's cool. And I saw a press release. I can't remember exactly when this was from. I'm not sure if it was even a press release, but this is a technology that you acquired then. Is that correct? So this, yeah, this technology is actually, the core technology is. has been in development since 1970s. Wow.

And it's over in India by Professor Guha. And the university system there has been testing this for decades, including a 13-year-long study, which is an incredibly long time, a 13-year-long luncheatel study, really showing how the system works. Then about 2010, it was brought to the United States by a nonprofit called the Parsimus Foundation

and became known as Vasilje. This is the core hydrogel. What we've done is, or I should say what they've done is done significant preclinical testing in animal models over the last 10 years. And then we partnered with them to commercialize it, to bring it to market. And really after a very, a lot of successful clinical preclinical studies, now we're going into the clinicals. Got it, got it. Cool. And just out of curiosity, this, I mean, I'm just trying to think like this, you're at the White House, right?

which I don't know if I've had any guess on that, have been to the White House, I guess. But maybe, maybe hypermen, we'll get in that in a little bit more detail. But this big problem, like, hits you like a brick, right? The face, as you described it, how do you go about, like, finding this particular gel, right? I mean, did you have to kind of, like, search far and wide?

Like, how did this, how did this even get on your radar? Yeah. So it's a few different ways. So I'm actually, I've long wanted it myself. And I was on the waiting list personally. And so I've known about it since it was brought to the United States. I signed up even as a teenager. I was like, this just makes sense.

Like, you know. And so I've been long following the progress. Vasil jails, many have referred to as the Kleenex of male birth control because it's just like it's the classic method. It's what it's been in development for so long. It's just what everyone's looked to. I also worked with the male contraceptive initiative, MCI, which is the world's largest nonprofit but dedicated to male birth control methods and they helped me to identify, you know, what is by far the most promising method.

And it was, again, landed on basal gel. And so we came in and really said, okay, what is needed to bring this to the world in an accessible way, right? Now that the hydro gel is very well known in terms of how it operates, what's needed. So how do you deliver it actually to a clinic? Like what are the tools that a doctor uses to do so to guarantee or to maximize, I should say, the success rate. So there's no risk of complications or to minimize risk, I should say. Got it.

Okay, cool. Yeah. So this is, I mean, it sounds like this has been, this has been something that you're aware of for quite some time. And you've been able to figure out, okay, sort of connect the dots in essence, right? Connect the puzzle pieces together to sort of form a real entity around this, around this technology. That's cool. And then give us a high-level sense of where you guys are at now. Are you still in clinical trials? Are you sort of prepping for eventual commercialization? Give us a sense for where this is at. Yeah, we're planning to launch our clinical trials here in the next six months. So we're working with the FDA and going through that process to get approval to launch clinical trials here in the United States. And then that will allow us to go through the formal approval. Again, we have decades of data. already in hand. And now it's just going through the process with the FDA. Got it, got it. So we're recording this and kind of call it mid Q3 of 23. So if you're

listening to this after the fact, you know, hopefully plan A will be in trials, maybe early 24-ish. Exactly. Yeah, okay, got it. 24. And we're hoping to be in market by late 25. So right around the corner. Got it, got it. Is it a, is it a PMA pathway? Or is it a different regulatory? Like, what's the regulatory pathway for? Yeah. We're working with the FDA on that. But we're really the benefit of this approach is while a lot of people are looking at a lot of different pharmaceutical and drug-based methods, the beautiful thing here is that it's because it operates mechanically with the body and as a mechanical filter, it's a medical device. Got it.

Cool. Awesome. So that's a super helpful overview. Let's spend maybe the next 20 to 30 minutes or so kind of going back in time, right, and learning a little bit about your journey and kind of like all of the experiences, right? maybe at White Fox and how you're playing them to Plan A. But for those listening that don't get a chance to read the full summary for this article, again, the company is Next Life Sciences.

It's what's the best website for next? Yeah, Plan A4Minn.com. Plan A for Men. Okay. Next Life Sciences is kind of the umbrella company, so to speak, and then Plan A for Men is the site Plan A for Men.com. That's where you can go learn about the team, the technology, So definitely I encourage everyone to head over there if you don't get a chance to read the full summary for this particular interview.

So, Luke, let's go back in time and talk a little bit about kind of what led up to, you know, forming Next, like, life sciences and plan A. You mentioned before that you've, you have a fair amount of experience now operating in regulated industries, right? And I'm sure maybe that or that specific to the device space, but you've, you know, I'm sure you've burned yourself a couple times or, you know, you probably had a lot of efficient, you know, projects go. way too. But when you kind of think about like some of the things and learnings that you're applying to Plan A in these early phases of like development, now, yes, maybe the core technology was already there, but you're having to tweak it for a very specific application. You know, what are you learning? Like how are you doing it different this time versus maybe, you know, other regulated, you know, projects that you've worked on maybe five, ten years ago?

When you look at the new market, right, and a new category, one of the things that I've really found is that a rising tide really does raise all ships. And it's really easy for people to get hyper competitive. And maybe there's a time and space for that. But when you're creating a new industry, I think it's something I've found is instead of looking at people's competition, to really say, like, how do we partner together to create something here? Like, we're on the same team. And if this is worthwhile, then there's a big enough market for a lot of players. Right. And so like for me, when I started my last company, my last company, White Fox, as you mentioned, there wasn't like, there was no name to the industry. And it was, I got laughed out of most every room that I was in. And in fact, it was illegal to do. So we, so I had to move my, my butt over to Washington, D.C. and get two federal laws passed to create now what's a multi-billion dollar industry there. Luckily, we don't need new legislation here. but it's still that mindset.

And it was something that I think a lot of people in that space were very confused about. It's like, why are you investing all of these resources in, you know, in this legislation? And it's like, well, that's how we actually create a real industry. Like we can, you know, nibble on crumbs here or we can actually do what's needed. Because if you have that focus on the mission, you say, like, what is it that we're actually trying to accomplish? It doesn't matter if I accomplishes or someone else accomplishes it, right? At the end of the day, it's accomplishing the mission. I believe that I'm best equipped and I have the best resources and the best vision for

how to accomplish the mission, for sure. But at the end of the day, like, it's about being mission driven that allows you to really be able to sleep at night knowing that what you're doing matters. Yeah. That reminds me of a podcast interview. I just listened to a few days ago. And then the guest's name is escaping me, but he's like a serial entrepreneur, kind of probably most well known for starting RV share.

And he mentioned, he was like, look, one of the biggest things that I've realized is you spend roughly about the same amount of time building a small business as you do going after building a really, really large business. And he's like, I fortunately kind of choose to try to build large, you know, spend most of that time, you know, taking a swing at a large, a very large market. It kind of sounds similar what you're talking about is like, if I'm going to, going to do the work here, I kind of want to create a big category and go after a very, very large market. So interesting. And so as, as, that kind of translates to, you know, plan A as an example.

Every early stage company still needs to be pretty efficient, right, with their dollars early on, right? It's not like you can, you know, most people that are listening to this kind of fully realize that you can't, you don't have endless resources to work with. So like from your perspective, like, what are some of the keys, right? To kind of really try to run pretty lean early on until you kind of have sort of traction, I guess, with your, you know, your alpha and beta versions of your product. If you're doing something that matters, right, and something that has that mission focus, I think that one of my philosophies is that there's, like, we go through life and it's this process

of exchange. We exchange our time. We exchange our money. We change, you know, all the resources that we have. And money is by far the easiest and the cheapest and laziest way to compel people to join in your mission. I think it's really important to like to, and I found a lot of success and just seeing people as humans, like no matter what, who they are, where, you know, who they work for, what title they have or what their experience has been.

Like everybody is a human and everybody has something that matters to them and a reason that drives them. And from by far, most people, it's not money, right? Money is what makes the world go around for sure. But I've, one of the advice that I give to, and that I've seen a lot of. of success in companies that I mentor and founders I mentor is helping them to see when you're interviewing somebody and you're like find out really what is it that drives them. Why are they there? And it could be anything for like I've had wildest array of different reasons that

people are sitting there interviewing with you. And if you can find creative ways to support them, then you'll be, you know, you'll be the one company that they want to work with. And you're able to operate in a way that brings about, you know, benefit to them individually, which produces better, more efficient and effective results. Got it. Got it. Yeah. Understanding kind of who you're working with and being able to step inside your shoes is

definitely a common theme that's kind of surfaced, I guess, in a lot of these, a lot of the conversations I've had with other, you know, med tech and health tech founders and CEOs. But let's transition to kind of a somewhat similar topic, right? And I think this is probably right up your alley, right? Even though a lot of your experience has been building white fox, but it's in a very regulated industry. And so when most, when most folks like step into the kind of the world of FDA and are working on a device or a biotech product or whatever have you,

they look at this, this clean reg kind of pathway and it's daunting, right? It's so it can be, you know, really overwhelming, even if it's, you know, reasonably straightforward. So as someone who's yes, has a lot of experience in a, in regulatory industries but is relatively new to kind of the life sciences per se. How are you approaching this process with plan A? I think it's really easy to look at regulators and blame them and a lot of people like to do that. It's really easy. What I found is that regulation is actually can create a lot of opportunity. In prior industries I was in, so before White Fox, I had another company that was in the

regulate space and that was manufacturing drones. And it was at the very beginning of the industry. And everybody was pushed back so hard on any thought of it being regulated. And I was one of the loud advocates and worked with some amazing people to say, no, we want this regulated. Like, in order to create a market here, we have to create public trust. And public trust comes through regulation. It comes through people knowing that what they're signing up for has been safe and effective. And I think that's what a lot of people miss when they see regulation is this like overbearing or something like, you know, short-sighted. You know, like that's the long game. The long game is having something that is enduring beyond just a really neat idea or a great product, but truly

something that can create precedent for other innovations. that are for future generations to be able to build upon with that trust and confidence that only comes through regulation. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010.

This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadine Miaria, CEO of CVRX and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium. Again, that's Medsiderradio.com forward slash premium.